Antiseptic preparation of patient's skin for surgery conventionally includes a 3–10 minute scrubbing of the affected area with a soap solution followed by the application of a water-soluble antiseptic paint solution. These solutions are generally applied with saturated sponges attached to a blade or held with forceps. These sponges are often saturated by soaking them in open pans of solution. Sometimes, sponges with attached handles are provided in a plastic pouch containing enough liquid to saturate the sponges.
While inexpensive, these techniques are messy and offer little control over inadvertent dripping of the solution into areas where it is undesired. Because many of the available solutions contain active ingredients such as alcohol and iodine, good control over the application has long been desirable.
Devices have been developed in an attempt to prevent the dripping of solution associated with these early techniques, and to reduce the time required for application of the antiseptic solution. In particular, the DURAPREP products commercially available from 3M Company of St. Paul, Minn. have enjoyed commercial success by providing substantially drip-free, convenient application. U.S. Pat. No. 4,925,327 describes a liquid applicator that incorporates a rigid, porous metering insert to regulate the flow rate of liquid disposed between the applicator handle and a foam sponge covering a major orifice of the handle. The liquid to be dispensed is contained in a rupturable reservoir removably affixed at the other major orifice of the handle.
U.S. Pat. No. 5,658,084 further discloses a liquid applicator in which the liquid is contained in a frangible ampoule inside the body of the applicator. This ampoule is supported and protected by a deformable element that prevents unintentional breakage of the ampoule from impacts during storage and handling before use. The applicator is actuated by pushing at least a portion of the frangible ampoule through an aperture in the deformable element and into contact with a means for breaking the ampoule.
Such ampoules are made of glass, in spite of the fact that sealed glass ampoules are relatively expensive. Many clinicians prefer to apply the prep in full aseptic attire (including sterile surgical gloves) and, therefore, it is important that the applicator that will be touched by those gloves be provided in a sterile condition. And since, for example, iodine based solutions decompose with exposure to gamma irradiation, manufacturers turn to gas sterilization with ethylene oxide gas to sterilize the outer surface of the container. Iodine solutions can form toxic by products such as iodohydrin (2-iodoethanol) when exposed to ethylene oxide sterilization, so they must be protected from exposure to this sterilant. Glass is a good barrier to agents such as ethylene oxide, unlike many other commonly used medical packaging materials, and so has been the material of choice for containing the prep solutions in spite of its cost.
While these described products have provided considerable advances, they are complex to manufacture, placing them beyond the means of some health care consumers. The art could still benefit from an applicator that could provide convenient, substantially drip-free dispensing of surgical preps at a lower cost.